Understanding Medical Communications and the Publication Planning Process
Even for a primary manuscript reporting the results of a clinical trial, the publication planning process is complicated. The Write Source collaborates with the client’s Publications Planning team to understand the timing of, and changes to, their clinical trial program. The data dissemination strategy must align with data availability, abstract deadlines, and dates of important congresses. Abstract development and reviews must be carefully orchestrated, as submission deadlines cannot be missed. Manuscript development involves identifying the audience of interest, targeting an appropriate journal, and managing the writing, review, and revision steps, which often undergo multiple cycles.
Overall, it is a dynamic, constantly evolving process, requiring flexibility, responsiveness, and preparedness at all times. The Write Source has effectively assisted dozens of clients with the presentation and publication of clinical data for nearly 20 years. The schematic below illustrates the complex nature of the process and highlights all of the steps and stages with which The Write Source helps our clients.
Clinical Trial (Sponsor)
Study
Protocol
Conduct
Study
Clinical Trial (Agency)
Publication
Agreement
CSR and
Data Tables
Identify/Invite Authors
Publication Planning
Identify Congresses
Prioritize Manuscripts
Poster/Slides Development
Present
Author Review/
Approval
Develop Poster/
Slides
Notification of Abstract
Acceptance
Abstract Development
Submit
Abstract
Author Review/
Approval
Develop
Abstract
TWS can manage the entire process
TWS can
provide assistance
Manuscript Development
Author Approval
Final Draft
Internal/
External
Review
2nd Draft
Internal/
External
Review
1st Draft
Internal/
External
Review
Outline
Internal/
External
Review
Kick-off, Content, Journal
Submission
Disclosures, Acknowledgments, Cover Letters
Submit
Online
Review Process
Peer
Review
Journal Decision
Journal Response & Resubmission
With
Response
Letter
Revise
Manuscript
Author
Review/
Approval
Resubmit
Publication
Page
Proofs
Online/